FDA approves expanded labeling on Medtronics SelectSecure MRI SureScan Model 3830 cardiac lead for conduction system pacing.
Federal Register notice: FDA announces the Advancing Real-World Evidence (RWE) Program, which was agreed to under the recent user fee reauthorization....
Federal Register notice: FDA extends the comment period associated with a 9/30 notice on the proposed recommendations for the reauthorization of the A...
Federal Register notice: FDA makes available a final guidance #253 entitled Current Good Manufacturing Practice for Animal Cells, Tissues, and Cell- a...
FDA publishes a guidance on accounting for multiple endpoints in the analysis of drug and biologic clinical trials.
Talaris says it has informed FDA about the death of a subject in the FREEDOM-1 trial of FCR001 in live donor kidney transplant recipients.
FDA releases the form FDA-483 with two observations from an inspection at Branchburg, NJ-based ImClone Systems.
Former CDRH cybersecurity acting director Kevin Fu says the best companies are already submitting software bills of materials with their 510(k) and PM...
